Osteocrin and Vascular Complications

Recruiting

• Conditions: Whether Osteocrin Levels Are Associated With Glycemic Control, Vascular Disorders in Diabetic Patients
• Interventions: Diagnostic Test: osteocrin

• Registration Number: NCT05719740
• Lead Sponsor: Assiut University

Brief Summary

In this study, we aimed to describe the role of bone-derived factor (osteocrin) in glucose metabolism, micro and macrovascular complications in diabetic patients. Thus, further investigations of the endocrine system through bone-derived hormones may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus.

Detailed Description

Diabetes mellitus (DM) remained the most common metabolic disorder worldwide occupying the 8th leading cause of death.\[1\] Defining new predictive biomarkers in diabetes would provide a window of opportunity for preventive and/or therapeutic interventions to prevent or delay the onset of irreversible long-term micro and or macro vascular complications. Progressive micro vascular vaso-degeneration is the major factor in progression of diabetic complications and contribute greatly to the increased mortality and morbidity. \[2\] Where Hemodynamic-mediated vascular injury was considered as one mechanism in the pathogenesis of diabetic nephropathy. \[3\] Bone disorders have been drawing attention as a novel diabetic complication, and diabetes is associated with an increased risk of osteoporotic fracture \[4-6\]. Bone is considered as an endocrine organ that influences various organs and tissues via the secretion of multiple bone derived hormones \[7-8\]. These endocrinal functions are, for example, glucose homeostasis \[9\], appetite control \[10\], fat deposition \[11\], skeletal muscle adaptation \[12\], male fertility \[13\], and cognition \[14\].

Therefore, these bone-derived hormones can become useful biomarkers for predicting the incidence of diabetes and the progression of diabetic complications. Osteocrin (OSTN), a bone-derived humoral factor, is a small secreted peptide cloned from bone and muscle complementary DNA (cDNA) libraries \[15\]. Osteocrin (Ostn) is secreted protein produced by cells of the osteoblast lineage that shows a well conserved homology with members of the natriuretic peptide (NP) family with prohormone-like characteristics \[17\]. To date, the exact role of Ostn has not been elucidated.

In this study, we aimed to describe the role of bone-derived factor (osteocrin) in glucose metabolism, micro and macrovascular complications in diabetic patients. Thus, further investigations of the endocrine system through bone-derived hormones may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study Start: 2023-02
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Cases of the study will select randomly, based on inclusion criteria that included

• Patients were diagnosed with diabetes mellitus according to American Diabetes Association
• Age range 20-70 years
• No apparent vascular abnormalities and Acute complications

Exclusion Criteria

• Patients are excluded for participation in the study if

  • Patients had past history of cardiovascular events (heart failure or history of coronary artery disease),
  • infections,
  • aacute diabetic complications,
  • diabetic patients on regular hemodialysis .
  • acute illness, malignancy, or pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
and 45 patients in type 2DM	osteocrin	TYPE 2 DIABETES MELLITUS
45 patients in type 1 .DM	osteocrin	TYPE 1 DIABETES MELLITUS

Primary Outcome Measures

Name	Time	Method
to test and evaluate the role of bone-derived factor (osteocrin) in glucose metabolism,in diabetic patients with risk of micro and macrovascular complications .	2 years

Secondary Outcome Measures

Name	Time	Method
to identify bone-derived factor (osteocrin) may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus	1 year

Trial Locations

Locations (1)

walaa soliman Hussien; 🇪🇬 Assiut, Egypt